ANI Pharmaceuticals

ANI Pharmaceuticals reported Q3 2024 net revenues of $148.3 million (+12.5% YoY) and Purified Cortrophin® Gel net revenues of $52.6 million (+76.8% YoY). The company posted a net loss of $(24.2) million and adjusted non-GAAP EBITDA of $35.1 million. Diluted GAAP loss per share was $(1.27), and adjusted non-GAAP diluted earnings per share were $1.34. ANI completed the acquisition of Alimera Sciences, Inc., implemented a new capital structure reducing annual interest expense by $39.0 million, and increased 2024 guidance to $594 million to $602 million in net revenues.

Investigative investing combines investigative experience with mass collaboration to identify undervalued stocks with significant price-moving information. The author holds a beneficial long position in ANIP shares.

Recursion's AI-driven drug REC-3964, an oral, non-antibiotic small molecule, has dosed its first patient in Phase II ALDER trial for recurrent Clostridioides difficile infection. REC-3964 targets toxin B's glucosyltransferase activity, differing from antibiotics by preserving gut microbiome. The trial aims to assess safety, tolerability, and efficacy, with results expected in Q4 2025. RecursionOS, the AI platform, accelerates drug development, reducing time and cost.

ANI Pharmaceuticals launched estradiol gel, 0.06% after FDA approval, aiming to provide a limited-competition product with annual US sales of $16.7 million.

ANI Pharmaceuticals launched Estradiol Gel, 0.06% after FDA approval, a generic version of EstroGel Gel, 0.06%, with U.S. annual sales of about $16.7M.

ANI Pharmaceuticals launched Estradiol Gel, 0.06% after FDA approval, aiming to provide a limited-competition product with annual U.S. sales of $16.7 million.

Alnylam Pharmaceuticals submitted a Type II Variation to the European Medicines Agency for vutrisiran, an RNAi therapeutic for ATTR amyloidosis with cardiomyopathy, supported by positive phase III HELIOS-B study results. The company already markets vutrisiran in the EU as Amvuttra for hATTR amyloidosis. If approved, vutrisiran could become the new standard of care for ATTR-CM, expanding the eligible patient population and driving growth.

Generic drug repurposing in oncology faces challenges due to lack of financial incentives and focus on de novo drug development. Nonprofits and non-manufacturers are advancing this field, but regulatory approval for new indications is difficult. A proposed 'labeling-only 505(b)(2) NDA' could streamline approval for non-manufacturers, increasing utilization of low-cost generics and improving patient outcomes.